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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 021180


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NDA 021180 describes ORTHO EVRA, which is a drug marketed by Janssen Pharms and is included in one NDA. Additional details are available on the ORTHO EVRA profile page.

The generic ingredient in ORTHO EVRA is ethinyl estradiol; norelgestromin. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.
Summary for 021180
Tradename:ORTHO EVRA
Applicant:Janssen Pharms
Ingredient:ethinyl estradiol; norelgestromin
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Nov 20, 2001TE:RLD:Yes

Expired US Patents for NDA 021180

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ORTHO EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180-001 Nov 20, 2001 ⤷  Subscribe ⤷  Subscribe
Janssen Pharms ORTHO EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180-001 Nov 20, 2001 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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